Growing Up: Intervening with HIV-Positive Adolescents in Resource-Poor Settings

 描述(申请人提供)：随着儿童艾滋病毒感染已从一种致命疾病转变为一种慢性病，越来越多的年轻人正在度过青春期，面临成年艾滋病毒感染人群的所有挑战，但基本上没有类似的治疗结果或证据基础来改善对抗逆转录病毒治疗(ART)和预防行为的坚持。尽管自抗逆转录病毒疗法推广以来，艾滋病毒发病率和死亡率总体上有所下降，但在年轻人中两者都有所上升。拟议的为期3年的R34发展研究的目标是响应这一量身定制研究的需求，特别是在HIV+年龄较大的青少年中，并有助于了解在资源有限的情况下将照顾者纳入坚持和降低风险计划的附加值。尽管照顾者的参与与艾滋病毒+青少年的结果有公认的相关性，但还没有关于照顾者在艾滋病毒+老年青少年结果中的作用的严格研究。该项目将整合护理者参与和认知行为干预(CBI)元素，以改善在资源匮乏的临床环境中接受治疗的艾滋病毒+老年青少年对抗逆转录病毒治疗的依从性和艾滋病毒风险的降低。我们建议的研究人群将包括照顾者和15至19岁的艾滋病毒携带者，他们知道自己的状况，并在海地太子港接受抗逆转录病毒治疗。在发展敏感信息-动机-儿童坚持行为技能(IMB-PED)的理论框架指导下，我们将发展成长(海地克里奥尔语中的N‘ap Grani)，作为照顾者-青少年参与关键信息、动机和行为技能的合作模式，这些技能是坚持和降低风险的关键因素。这项拟议的研究与海地最大的青年保健提供者FOSREF合作，并建立在先前在太子港与艾滋病毒携带者青年和成年人合作的基础上。这项研究将利用定性和定量方法：确定遵守和减少风险的障碍和促进者(目标1)；开发和预测N‘ap Grani，包括适合发展的手册、培训材料、程序和心理测量措施的适当性(目标2)；并在一项三臂随机对照试验(RCT)中评估可行性和初步疗效，其中120名青年将被分配到三组：实验照料者-青少年N‘ap Grani组、青少年专用版本(N’ap Grani-A)和青少年专用健康促进组(HP-A)，从卫生中心的角度检查ART依从性和病毒学反应、艾滋病毒危险行为、积极沟通和监测、压力和情绪以及费用(目标3)。在海地，与世隔绝、交流受阻、照顾者痛苦、青少年不遵守抗逆转录病毒药物和艾滋病毒风险非常高，这是全球儿童艾滋病毒在普遍流行的低收入和中等收入国家(LMIC)流行的一个缩影。继撒哈拉以南非洲地区之后，加勒比地区是世界上艾滋病毒感染最严重的地区，50%的艾滋病毒感染者生活在海地。我们提议的研究将是海地针对HIV+青少年的第一次量身定做的干预和RCT试点，并将代表全球为数不多的LMIC之一。

 DESCRIPTION (provided by applicant): As pediatric HIV infection has shifted from being a fatal disease to a chronic illness, a growing cohort of young people are moving through adolescence with all the challenges of the adult HIV-infected population but largely without comparable treatment outcomes or an evidence base to improve adherence to antiretroviral treatment (ART) and preventive behavior. Despite overall declines in HIV incidence and mortality since the ART scale-up, both have risen among youth. The goal of the proposed 3-year R34 developmental study is to respond to this need for tailored research, in particular among HIV+ older adolescents, and contribute to understanding the added value in resource-limited settings of including caregivers in an adherence and risk reduction program. Although caregiver involvement is a recognized correlate of outcomes in HIV+ youth, there are no rigorous studies of the role of caregivers in outcomes among HIV+ older adolescents. This project will integrate caregiver involvement and cognitive behavioral intervention (CBI) elements to improve ART adherence and HIV risk reduction for HIV+ older adolescents treated in resource-poor clinical settings. Our proposed study population will include caregivers and 15 to 19 year-old HIV+ youth who know their status and are receiving ART in Port-au-Prince, Haiti. Guided by the theoretical framework of the developmentally sensitive Information-Motivation-Behavioral Skills for Pediatric Adherence (IMB-PED), we will develop Growing Up (N'ap Grandi, in Haitian Creole) as a collaborative model of caregiver-adolescent engagement in the key informational, motivational, and behavioral skills antecedents of ART adherence and risk reduction. The proposed study partners with Haiti's largest youth health provider, FOSREF, and builds upon prior work with HIV+ youth and adults in Port-au-Prince. The study will utilize qualitative and quantitative methods to: identify barriers and facilitators to adherence and risk reduction (Aim 1); develop and pretest N'ap Grandi, including developmentally-appropriate manuals, training materials, procedures, and psychometric adequacy of measures (Aim 2); and assess feasibility and preliminary efficacy in a 3-arm randomized controlled trial (RCT), in which 120 youth will be assigned to three groups: the experimental caregiver-adolescent N'ap Grandi, an adolescent-only version (N'ap Grandi-A) and an adolescent-only health promotion group (HP-A), examining ART adherence and virologic response, HIV risk behaviors, positive communication and monitoring, stress and mood, and costs from the health center perspective (Aim 3). Isolation, inhibited communication, caregiver distress, adolescent ART non-adherence and HIV risk are very high in Haiti, which is a microcosm of the global pediatric HIV epidemic in low and middle income countries (LMICs) with generalized epidemics. After sub- Saharan Africa, the Caribbean is the most HIV-affected region in the world, with 50% of people with HIV infection living in Haiti. Our proposed study will be the first tailored intervention and RCT pilotd for HIV+ adolescents in Haiti, and will represent one of only a handful in LMICs globally.